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FDA 510(k)

ZEOBI

K-Number: K121338 · 2012-07-27

ApplicantIvivi Health Science, LLC
Decision Date2012-07-27
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ZEOBI is the device name listed in this FDA 510(k) record. The listed applicant is Ivivi Health Science, LLC. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K121338. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEOBI?

ZEOBI is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Ivivi Health Science, LLC. The 510(k) number is K121338.

When did ZEOBI receive FDA 510(k) clearance?

ZEOBI received FDA 510(k) clearance on 2012-07-27, under 510(k) number K121338.

Who is the listed applicant for ZEOBI?

The FDA 510(k) record lists Ivivi Health Science, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEOBI?

The FDA product code for ZEOBI is ILX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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